A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02641392
• Other study ID #: GED-0301-CD-004
• Status: Terminated
• Phase: Phase 3
• Start date: July 25, 2016
• Est. completion date: January 4, 2018

Study information

• Verified date: January 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The GED-0301-CD-003 trial was not initiated; see detailed description.

Description:

This is a long-term active treatment study in patients with Crohn's disease (CD). Subjects who met the early escape criteria in Study GED-0301-CD-002, or subjects who completed Study GED-0301-002 or GED-0301-003, may be eligible for this study. Primary objective is to assess long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be explored.

There are 5 possible treatment groups for GED-0301-CD-002 Subjects (Groups 1-5). There are 3 possible treatment groups for GED-0301-CD-003 subjects (Groups 1-3). Treatment is assigned based on clinical improvement achieved or not achieved from the core GED-0301 study.

1. continuous GED-0301 160 mg once daily for 12 weeks, followed by alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;

2. alternating GED-0301 160 mg once daily for 4 weeks with placebo once daily for 4 weeks, through Week 208;

3. alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;

4. continuous GED-0301 40 mg once daily through Week 208;

5. alternating placebo once daily for 4 weeks, followed by GED-0301 40 mg once daily for 4 weeks, through Week 208.

The GED-0301-CD-003 trial was not initiated; the GED-0301 program was terminated; no safety findings were noted.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 310
• Est. completion date: January 4, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria for Adult Subjects:

Subjects must satisfy the following criteria to be screened and enrolled in the study:

• Male or female = 18 years of age.

• Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.

• Subject must use protocol approved contraception.

Inclusion Criteria for Adolescent Subjects:

Adolescent subjects must satisfy the following criteria to be screened and enrolled in the study

• Male or female 12 to 17 years of age.

• Subject must have participated in the GED 0301 CD 003 study.

• Subject is able to swallow the IP tablets.

• Subject must use protocol approved contraception.

Exclusion Criteria for Adult and Adolescent Subjects:

The presence of any of the following will exclude a subject from screening and enrollment:

• Subject had experienced a serious adverse event (SAE) related to the investigational product while participating in the previous Phase 3 GED-0301 study.

• Subject has initiated biologic agents, such as TNF-a blockers or integrin antagonists.

• Subject is pregnant or breastfeeding.

• Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any ingredient in the investigational product.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• GED-0301
Mongersen

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Monash Medical Centre Clayton	Bentleigh East
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Centre For Digestive Diseases	Five Dock	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Mater Adult Hospital	South Brisbane	Queensland
Austria	LKH Universitaetsklinikum Graz	Graz
Austria	Medizinische Universitat Innsbruck	Innsbruck
Austria	KH der Barmherzigen Bruder Linz	Linz
Austria	LKH - Universitätsklinikum der PMU Salzburg	Salzburg
Austria	KH der Barmherzigen Brüder St.Veit an der Glan	St Veit An Der Glan
Austria	AKH Medizinische Universitat Wien	Wein
Austria	Krankenanstalt Rudolfstiftung Wien	Wein
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	UZ Leuven	Leuven
Belgium	CHU Sart Tilman	Liege
Bulgaria	MHAT Kaspela EOOD	Plovdiv
Bulgaria	MHAT Ruse AD	Ruse
Bulgaria	City Clinic UMHAC EOOD	Sofia
Bulgaria	MHAT Doverie AD	Sofia
Bulgaria	Second MHAT Sofia AD	Sofia
Bulgaria	UMHAT Sv Ivan Rilski EAD	Sofia
Bulgaria	UMHAT Tsaritsa Yoanna - ISUL EAD	Sofia
Canada	Brandon Medical Arts Clinic	Brandon	Manitoba
Canada	University of Calgary	Calgary	Alberta
Canada	South Edmonton Gastroenterology	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Centre de sante et de services sociaux Champlain Charles Le Moyne	Greenfield Park	Quebec
Canada	McMaster University Health Sciences Center	Hamilton	Ontario
Canada	LHSC Victoria Hospital	London	Ontario
Canada	London Health Science Center U. Hospital	London	Ontario
Canada	McGill University Health Centre Glen Site Royal Victoria Hospital	Montreal	Quebec
Canada	Montfort Hospital	Ottawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	GI Research Institute	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates Inc	Vaughan	Ontario
Canada	PerCuro Clinical Research	Victoria	British Columbia
Canada	Medicine Professional Corporation	Waterloo	Ontario
Croatia	Clinical Hospital Centre Osijek	Osijek
Czechia	Fakultni nemocnice u sv Anny v Brne	Brno
Czechia	Hepato-Gastroenterologie HK	Hradec Kralove
Czechia	PreventaMed	Olomouc
Czechia	CCBR Prague CZ	Praha 3
Denmark	Aarhus Universitetshospital	Aahus C
Denmark	Alborg Universitets Hospital	Alborg
Denmark	Nordsjaellands Hospital Frederikssund	Frederikssund
Denmark	Herlev Hospital	Herlev
Denmark	Koge Sygehus	Koge
Denmark	Regionshospitalet Silkeborg	Silkeborg
France	CHU Amiens Hopital Sud	Amiens Cedex
France	CHU Besancon Hopital Jean Minjoz	Besancon Cedex
France	CHU Tours Hopital Trousseau	Chambray les Tours
France	CHU Clermont Ferrand	Clermont-Ferrand
France	Hopital Beaujon	Clichy cedex
France	CHU Nantes Hotel Dieu	Nantes Cedex 1
France	CHU Nice Hopital de lArchet 2	Nice Cedex 3
France	Groupe Hospitalier Sud Hopital Haut Leveque USN	Pessac
France	Centre Hospitalier Lyon Sud	Pierre Benite cedex
France	CHU Reims Hopital Robert Debre	Reims
France	CHU Rennes Hopital Pontchaillou	Rennes cedex 09
France	CHU Saint Etienne Hopital Nord	Saint Etienne
France	CHU Strasbourg Hopital Hautepierre	Strasbourg Cedex
France	CHU de Toulouse Hopital Rangueil	Toulouse Cedex 09
France	Hopital de Brabois Adultes	Vandoeuvre les Nancy
Germany	Charite Universitaetsmedizin Berlin Campus Benjamin Franklin	Berlin
Germany	DRK Kliniken Berlin Westend	Berlin
Germany	Krankenhaus Waldfriede e V	Berlin
Germany	Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH	Bochum
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	Kliniken Essen-Mitte	Essen
Germany	Agaplesion Markus Krankenhaus	Frankfurt
Germany	Universitaetsklinikum Halle Saale	Halle
Germany	Asklepios Klinik Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter	Heidelberg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Jena	Jena
Germany	Universitaetsklinikum Schleswig Holstein Campus Kiel	Kiel
Germany	EUGASTRO GmbH	Leipzig
Germany	University Leipzig	Leipzig
Germany	Medizinisches Zentrum Klinikum Lueneburg	Lueneburg
Germany	Klinikum Mannheim GmbH Universitaetsklinikum	Mannheim
Germany	Gastro Campus Research	Muenster
Germany	Klinikum der Universitaet Muenchen	München
Germany	Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer	Niedersachsen
Germany	Universitaetsklinikum Regensburg	Regensburg
Germany	Universitaetsklinikum Ulm	Ulm
Greece	University General Hospital of Alexandroupolis	Alexandroupolis
Greece	Athens Medical Center	Athens
Greece	General Hospital of Athens Evangelismos	Athens
Greece	University General Hospital of Patras	Rio Patras
Hungary	DRC Gyogyszervizsgalo Kozpont Kft	Balatonfured
Hungary	Endomedix Diagnosztikai Kozpont	Budapest
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Semmelweis Egyetem AOK	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Szent Pantaleon Korhaz Rendelointezet Dunaujvaros	Dunaujvaros
Hungary	Petz Aladar Megyei Oktato Korhaz	Gyor
Hungary	Clinfan Szolgaltato Kft	Szekszard
Israel	HaEmek Medical Center	Afula
Israel	Soroka University Medical Center	Beer Sheva
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah University Hospital	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rechovot
Israel	Tel Aviv Sourasky Medical Center Department of Hematology	Tel Aviv
Israel	The Baruch Padeh MC, Poriya	Tiberias
Israel	Assaf Harofeh Medical Center	Zerifin
Italy	Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi	Bologna
Italy	Azienda Ospedaliera Universitaria Policlinico G Martino	Messina
Italy	Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera Vincenzo Cervello	Palermo
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Policlinico Universitario Agostino Gemelli	Roma
Italy	Universita Campus Bio Medico di Roma	Roma
Italy	Azienda Ospedaliera San Camillo Forlanini	Rome
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Rome
Italy	Istituto Clinico Humanitas	Rozzano (MI)
Italy	IRCCS Policlinico San Donato	San Donato Milanese
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo FG
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Hanyang University Guri Hospital	Guri-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	CHA Bundang Medical Center CHA University	Seongnam-si,
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Latvia	Digestive Diseases Center Gastro	Riga
Latvia	Pauls Stradins Clinical University Hospital	Riga
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Radboudumc	Nijmegen
Netherlands	Zuyderland Medisch Centrum	Sittard-Geleen
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
Norway	Akershus universitetssykehus HF	Lørenskog
Norway	Oslo Universitetssykehus Rikshospitalet	Oslo
Poland	Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA	Kielce
Poland	Indywidualna Praktyka Lekarska Maciej Zymla	Knurow
Poland	SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow	Lodz
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	Endoskopia Sp. z o.o.	Sopot
Portugal	Hospital de Braga	Braga
Portugal	Hospital da Senhora da Oliveira Guimaraes	Guimaraes
Romania	S.C MedLife S.A	Bucuresti
Romania	CMI Dr. Tirnaveanu Amelita	Oradea
Romania	Centrul de Gastroenterologie Dr. Goldis	Timisoara
Russian Federation	TSBIH Territorial Clinical Hospital	Krasnoyarsk
Russian Federation	SBHI of NN region RCH of NN n.a. N.A.Semashko	Nizhny Novgorod
Russian Federation	FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS	Novosibirsk
Russian Federation	SBEIHPE Novosibirsk State Medical University	Novosibirsk
Russian Federation	Evromedservis	Pushkin
Russian Federation	SEIHPE Rostov State Medical University of MoH of RF	Rostov-on-Don
Russian Federation	SPb SBIH City Hospital # 26	Saint-Petersburg
Russian Federation	NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways	Samara
Serbia	Clinical Center Bezanijska Kosa	Belgrade
Serbia	Clinical Center Zvezdara	Belgrade
Serbia	Military Medical Academy	Belgrade
Slovakia	Fakultna nemocnica s poliklinikou F. D. Roosevelta	Banska Bystrica
Slovakia	Alian s.r.o.	Bardejov
Slovakia	Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.	Malacky
Slovakia	Fakultna nemocnica Nitra	Nitra
Slovakia	KM Management, spol. s r.o.	Nitra
Slovakia	GASTRO I., s.r.o.	Presov
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda
Spain	Corporacion Sanitaria Parc Tauli	Sabadell
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Danderyds Sjukhus AB	Stockholm
Switzerland	Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner	Bern
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Acibadem Fulya Hospital	Istanbul
Turkey	Haydarpasa Numune Training and Research Hospital	Istanbul
Turkey	Istanbul Medeniyet Uni Goztepe Training&Res Hosp	Istanbul
Turkey	Istanbul University Cerrahpasa Medical Faculty Hospital	Istanbul
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul
Turkey	Yeditepe University Medical School Hospital	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Kocaeli Derince Training and Research Hospital	Kocaeli
Ukraine	RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU	Chernivtsi
Ukraine	CI of PH Kharkiv CCH #2	Kharkiv
Ukraine	Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus	Kirovohrad
Ukraine	Kyiv City Clinical Hospital #1	Kyiv
Ukraine	SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU	Kyiv
Ukraine	Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC	Kyiv
Ukraine	CI Odesa Regional Clinical Hospital	Odessa
Ukraine	Ternopil City Communal Emergency Medical Care Hospital	Ternopil
Ukraine	CI Zaporizhzhia Regional Clinical Hospital of ZRC	Zaporozhje
United Kingdom	Royal Devon and Exeter Hospital Wonford	Exeter
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Glasgow Royal Infirmary	Glasgow, Scotland
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Royal London Hospital	London
United Kingdom	St Marys Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Nottingham University Hospitals Queens Medical Centre	Nottingham
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury
United States	Texas Clinical Research Institute LLC	Arlington	Texas
United States	Atlanta Gastroenterology Associates, LLC	Atlanta	Georgia
United States	Gastroenterology Associates LLC	Baton Rouge	Louisiana
United States	Ehrhardt Clinical Research LLC	Belton	Missouri
United States	ClinSearch LLC	Chattanooga	Tennessee
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Metropolitan Gastroenterology	Chevy Chase	Maryland
United States	Texas Digestive Disease Consultants - Dallas	Dallas	Texas
United States	Texas Digestive Disease Consultants - Southlake	Flower Mound	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Columbia University Medical Center	New York	New York
United States	Health Science Research Center, LLC	Pratt	Kansas
United States	Sagact Pllc	San Antonio	Texas
United States	San Antonio Military Medical Center	San Antonio	Texas
United States	Medical Associates Research Group Inc.	San Diego	California
United States	University of Washington School of Medicine	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Digestive Health Specialists of Tyler	Tyler	Texas
United States	The Vancouver Clinic	Vancouver	Washington
United States	Via Christi Research a division of Via Christi Hospitals Wichita Inc	Wichita	Kansas
United States	Trial Management Associates LLC	Wilmington	North Carolina
United States	Gastroenterology Associates of Western Michigan PLC	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208	A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED- 0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale; Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.	From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose